EUCTR2009-012576-27-PL进行中（未招募）1 期
Evaluation of Sorafenib in combination with local micro-therapy guided by Gd-EOB-DTPA enhanced MRI in patients with inoperable hepatocellular carcinoma - SORAMIC
Medical Faculty, University Magdeburg0 个研究点目标入组 710 人开始时间: 2010年9月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 710
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age: 18-85 years
- •2. Hepatocellular carcinoma
- •3. If extrahepatic metastases: liver-dominant disease
- •4. Stage BCLC A, B, or C
- •5. Child-Pugh A, Child-Pugh B up to 7 points
- •6. Willing to comply with all study procedures
- •7. Has voluntarily given written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 222
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 443
排除标准
- •1. If female, pregnant or breast feeding (females of child-bearing potential must use adequate contraception and must have a negative pregnancy test performed within 7 days prior to inclusion into this study)
- •2. If male, not using adequate birth control measures
- •3. One or more of the following:
- •- Hemoglobin <10g/dL,
- •- WBC <2,500 cells/mm3,
- •- ANC <1,500 cells/mm3,
- •- platelets <50,000/mm3,
- •- ECOG performance status >2
- •4. Life expectancy <16 weeks or medically unstable
- •5. Pulmonary metastases
- •6. Patients with known GFR <30 mL/min/1.73m2
- •7. PT-INR/PTT >1.5 times the upper limit of normal
- •8. uncontrolled infections at the time of microtherapy
- •9. Child-Pugh score >7 points;
- •10. Uncontrolled ascites
- •11. tumor load of the whole liver >70%
- •12. Contraindications for study medications according to product labeling or procedures
- •13. Having undergone surgical procedures with resection of the sphincter of Oddi
- •14. Significant cardiovascular disease; e.g., myocardial infarction within 6 months of inclusion, chronic heart failure (New York Heart Association class III or IV), unstable coronary artery disease
- •15. Uncontrolled hypertension
- •16. Thrombotic or embolic events including transient ischemic attacks within the past 6 months (tumor-related portal vein thrombosis allowed in the palliative part of the trial)
- •17. History of GI bleeding within 30 days befor inclusion into the study
- •18.History of esophageal varices bleeding which has not been controlled by effective therapy and/or therapy to prevent bleeding recurrence
- •19. Previous malignancy other than carcinoma in situ of the skin or the cervix uteri within 5 years prior to inclusion
- •20. History of organ transplant (including prior liver transplantation)
- •21. HIV, congenital immune defect, any immunosuppressive therapy for autoimmune disease (rheumatoid arthritis) or inflammatory bowel disease
- •22. Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
- •23. Close affiliation with the investigational site; e.g. first-degree relative of the investigator.
- •24. Participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 30 days of enrolment into this trial
- •25. Having been previously enrolled in this clinical trial
研究者
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